Alembic Pharma gets USFDA tentative approval for cancer drug

12 Jan 2026 , 02:45 PM

Alembic Pharmaceuticals Limited announced that it has secured tentative approval from the US Food and Drug Administration (USFDA) for its Bosutinib Tablets, 400 mg.

Alembic Pharma stated that it has received the tentative approval for its supplemental Abbreviated New Drug Application (sANDA). 

At around 2.34 PM, Alembic Pharma was trading marginally lower at ₹799.30 per piece, against the previous close of ₹799.95 on NSE. The counter touched an intraday high and low of ₹804.15, and ₹786, respectively.

The product is the therapeutic equivalent of Bosulif Tablets, 400 mg, marketed by PF Prism C.V., said the company.

Bosutinib is a kinase inhibitor that is used for the treatment of adult patients with conditions such as Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML). It also includes newly-diagnosed patients along with those who are resistant or intolerant to prior therapies. It is also indicated for treatment of patients with increased or blast phase Ph+ CML who have shown resistance or intolerance to earlier treatments.

The pharma business also announced that it has already secured final USFDA approvals for Bosutinib Tablets in the 100 mg and 500 mg strengths. The 400 mg dosage signifies an additional opportunity in the molecule’s lifecycle.

As per the details disclosed by the company, Bosutinib Tablets, 400 mg, had an estimated market size of $251 Million in the US for the year ended September 2025.

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